Clinical and service delivery implications of omitting ultrasound before medication abortion provided via direct-to-patient telemedicine and mail in the U.S.

OBJECTIVES: To compare outcomes among patients who did or did not have pre-abortion ultrasound or pelvic exam before obtaining medication abortion (MA) via direct-to-patient telemedicine and mail. STUDY DESIGN: We analyzed data from participants screened for enrollment into the TelAbortion study at five sites from March 25 to September 15, 2020. We compared participants who had preabortion ultrasound or pelvic exam ("test-MA") to those who did not ("no-test MA"). Outcomes were: abortion not complete with pills alone (i.e., had procedure intervention or ongoing pregnancy), ongoing pregnancy separately, ectopic pregnancy, hospitalization and/or blood transfusion, and unplanned clinical encounters. We used propensity score weighting and multivariable logistic regression to adjust for baseline characteristics. RESULTS: Our analysis included 287 participants who had no-test MA and 125 who had test-MA. Abortion was not complete with pills alone in 16of 287 (5.6%) no-test MA patients compared to 2of 123 (1.9%) test-MA patients (adjusted risk difference [aRD] = 4.3%, 95% confidence interval [CI]: 1.4%-7.1%). No ectopic pregnancies were detected. Groups did not differ regarding hospitalization and/or blood transfusion (p = 0.76) or ongoing pregnancy diagnosis (p = 0.59). Unplanned clinical encounters were more common in no-test MA patients (35of 287, 12.5%) than test-MA patients (10of 125, 8.0%, aRD = 6.7%, 95% CI: 0.5%-13.1%). CONCLUSIONS: Compared to patients who had pre-abortion ultrasound, patients who had no-test MA via telemedicine were more likely to have abortions that were not complete with pills alone and/or unplanned clinical encounters. However, both no-test and test-MA patients had similar and very low rates of ongoing pregnancy and hospitalization or blood transfusion. IMPLICATIONS: Omitting pre-abortion ultrasound before provision of medication abortion via telemedicine does not appear to compromise safety or result in more ongoing pregnancies. However, compared to patients who have preabortion ultrasound, patients who do not have pre-abortion tests may be more likely to seek post-treatment care and have procedural interventions.

Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic.

OBJECTIVE: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. STUDY DESIGN: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician. Sites sent study packages containing mifepristone and misoprostol by mail and had remote follow-up consultations within one month by telephone (or by online survey, if the participant could not be reached) to evaluate abortion completeness. The analysis was descriptive. RESULTS: We mailed 1390 packages between May 2016 and September 2020. Of the 83% (1157/1390) of abortions for which we obtained outcome information, 95% (1103/1157) were completed without a procedure. Participants made 70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%). Enrollment increased substantially with the onset of COVID-19. Although a screening ultrasound was required, sites determined in 52% (346/669) of abortions that occurred during COVID that those participants should not get the test to protect their health. Use of urine pregnancy test to confirm abortion completion increased from 67% (144/214) in the 6 months prior to COVID to 90% (602/669) in the 6 months during COVID. Nearly all satisfaction questionnaires (99%, 1013/1022) recorded that participants were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration. In some cases, participants did not need to visit any facilities to obtain the service, which was critical to protecting patient safety during the COVID-19 pandemic. IMPLICATIONS: Medical abortion using telemedicine and mail is effective and can be safely provided without a pretreatment ultrasound. This method of service delivery has the potential to greatly improve access to abortion care in the United States.

"False positive" urine pregnancy test results after successful medication abortion.

OBJECTIVE: To examine the proportion of high-sensitivity urine pregnancy test (HSPT) results that were positive by time after successful medication abortion. STUDY DESIGN: We used data from an ongoing study that provides mifepristone and misoprostol for medication abortion by direct-to-patient telemedicine and mail. Providers evaluated abortion outcomes by patient interview and clinical tests per clinical judgment and participant preference. We identified all participants enrolled July 2016 to September, 2020 who had an HSPT result and no indication of viable pregnancy after treatment. We used logistic regression to examine the association between the timing of the initial post-treatment HSPT, gestational age, and the proportion of HSPTs that gave a positive result. RESULTS: Of the 472 participants in our analysis, 88 (19%) had positive initial HSPTs. The proportions that were positive at ≤20 days, 21 to 27 days, 28 to 34 days, and ≥35 days after mifepristone ingestion was 14 of 29 (48%), 15 of 58 (26%), 49 of 258 (19%), and 10 of 127 (8%), respectively (p < 0.001). Gestational age at mifepristone ingestion was not significantly related to positive HSPT results (p = 0.28). Multivariable logistic regression confirmed both findings and did not identify a statistically significant interaction between these variables. In the 67 participants who relied solely on further HSPTs to confirm abortion outcome, the median interval between the initial positive test and first negative test was 14 days. CONCLUSIONS: The proportion of participants with positive HSPTs declined with time after successful medication abortion. However, nearly one-fifth of participants with complete abortion had positive tests 4 weeks after treatment. IMPLICATIONS: HSPTs provide an inexpensive, convenient option for confirming success of medication abortion at home. However, a substantial minority of patients without ongoing pregnancy have positive HSPT results. Development of a symptom-based strategy for medication abortion outcome assessment without any confirmatory tests should be a priority.